A Phase III Study of BMS-188667 in Children and Adolescents with Juvenile Rheumatoid Arthritis

• Conditions: Juvenile Rheumatoid Arthritis; MedDRA version: 14.0Level: LLTClassification code 10023267Term: Juvenile rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2005-000443-28-Outside-EU/EEA
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) Diagnosis of JRA or JIA utilizing the standard criteria for one of the following categories:
- JRA (ACR criteria): pauciarticular, polyarticular or systemic disease onset and polyarticular course
- JIA (ILAR criteria): extended oligoarticular, polyarticular (RF+), polyarticular (RF-), or systemic with a polyarticular course
2) Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease as defined by:
- = 2 active joints (i.e. presence of swelling, or if no swelling is present, limitation of motion (LOM) accompanied by pain, tenderness, or both)
- = 2 joints with limitation of motion (LOM) at screening and at study Day 1 visit.
- The same joint can separately meet the definition of an active joint and a joint with LOM
3) Subjects must have experienced an insufficient therapeutic response or intolerance in the opinion of the examining physician to at least on DMARD.
4) Males or females (not nursing and not pregnant) 6 – 17 years of age, inclusive at screening. Males and females of childbearing potential are eligible only if they practice effective contraceptive measures.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Subjects who have not previously experienced an insufficient therapeutic response or intolerance to at least one DMARD.
2) Systemic onset JRA or systemic JIA with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to JRA/JIA, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
3) Active uveitis.
4) Presence of any other rheumatic disease or major chronic
infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus erythematosus, etc.)
5) Presence of infection at screening or history of frequent acute or chronic infections within 3 months prior to the first dose of study medication.
6) Joint replacement surgery required during the anticipated time on study medication, including screening or history of surgery on more than 5 joints.
7) Live vaccines within 3 months of the first dose of study medication.
8) Active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified